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Title: Seamless Clinical Trials with Doubly Adaptive Biased Coin Designs
In addition to scientific questions, clinical trialists often explore or require other design features, such as increasing the power while controlling the type I error rate, minimizing unnecessary exposure to inferior treatments, and comparing multiple treatments in one clinical trial. We propose implementing adaptive seamless design (ASD) with response adaptive randomization (RAR) to satisfy various clinical trials’ design objectives. However, the combination of ASD and RAR poses a challenge in controlling the type I error rate. In this paper, we investigated how to utilize the advantages of the two adaptive methods and control the type I error rate. We offered the theoretical foundation for this procedure. Numerical studies demonstrated that our methods could achieve efficient and ethical objectives while controlling the type I error rate.  more » « less
Award ID(s):
2014951
PAR ID:
10462981
Author(s) / Creator(s):
; ; ;
Date Published:
Journal Name:
The New England Journal of Statistics in Data Science
ISSN:
2693-7166
Page Range / eLocation ID:
1 to 9
Format(s):
Medium: X
Sponsoring Org:
National Science Foundation
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